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The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02006888
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
ICON Bioscience Inc

Tracking Information
First Submitted Date  ICMJE December 5, 2013
First Posted Date  ICMJE December 10, 2013
Results First Submitted Date  ICMJE August 15, 2017
Results First Posted Date  ICMJE April 23, 2018
Last Update Posted Date April 23, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
Number of Participants With Anterior Chamber Cell Clearing [ Time Frame: Day 8 ]
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
The primary efficacy outcome is anterior chamber cell clearing (ACC = 0) in the study eye at Day 8. [ Time Frame: Day 8 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
Official Title  ICMJE The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery
Brief Summary The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.
Detailed Description A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammation
  • Cataracts
Intervention  ICMJE
  • Drug: IBI-10090
    Other Name: Dexycu
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: IBI-10090 low dose
    IBI-10090 low dose
    Intervention: Drug: IBI-10090
  • Experimental: IBI-10090 med dose
    IBI-10090 med dose
    Intervention: Drug: IBI-10090
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2015)
394
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2013)
352
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
  2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
  3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye.
  4. The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
  5. The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
  6. A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study.
  7. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.

Key Exclusion Criteria:

  1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
  2. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
  3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
  4. Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
  5. Patients with an allergy or hypersensitivity to dexamethasone.
  6. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
  7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
  8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
  9. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
  10. Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02006888
Other Study ID Numbers  ICMJE C13-04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ICON Bioscience Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ICON Bioscience Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: howard franklin, md ICON Bioscience Inc
PRS Account ICON Bioscience Inc
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP